Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT00001034
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed:
* Antiretroviral therapy.
* Anti-PCP prophylaxis.
* Maintenance or prophylaxis therapy for other opportunistic infections besides CMV.
Patients must have:
* Working diagnosis of HIV infection.
* CD4 count \<= 100 cells/mm3.
* Positive CMV serology (IgG) or CMV culture, in the absence of active disease, documented at any time prior to study entry.
* Reasonably good health.
* Life expectancy of at least 6 months.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
* Acute life-threatening illness.
* Active lymphoma.
* Hypersensitivity to acyclovir.
* Lack of willingness or ability, in the opinion of the clinician, to comply with protocol requirements.
Concurrent Medication:
Excluded:
* Vidarabine.
* Amantadine hydrochloride (Symmetrel).
* CMV hyperimmune globulin/intravenous immune globulin.
* Cytarabine.
* Fiacitabine (FIAC) or fialuridine (FIAU).
* Foscarnet.
* Intravenous ganciclovir.
* HPMPC.
* Idoxuridine.
* Intravenous acyclovir.
* Oral acyclovir at \> 1 g/day.
* Other drugs with potential anti-CMV activity.
Prior Medication:
Excluded within 60 days prior to study entry:
* Foscarnet.
Excluded within 2 weeks prior to study entry:
* Vidarabine.
* Amantadine hydrochloride (Symmetrel).
* CMV hyperimmune globulin/intravenous immune globulin.
* Cytarabine.
* Fiacitabine (FIAC) or fialuridine (FIAU).
* Ganciclovir.
* HPMPC.
* Idoxuridine.
* Intravenous acyclovir.
* Oral acyclovir at \> 1 g/day.
* Other drugs with potential anti-CMV activity.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Study:
NCT00001034
Study Brief:
Protocol Section:
NCT00001034